Psilocybin, a serotonin receptor agonist, is a component of some mushroom species

COMPASS Pathways announced that the Food and Drug Administration (FDA) has granted approval for a clinical trial with psilocybin therapy for treatment-resistant depression.

The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America. It is set to start in the United Kingdom later this month and sites in other countries will join the trial as additional regulatory approvals are received. If the Phase 2b trial is successful, the Company plans to conduct Phase 3 studies to compare the optimal dose with placebo or standard of care.